Package leaflet: Information for the user

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Bupropion Neuraxpharm, 300 mg, modified-release tablets
Bupropioni hydrochloridum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are similar.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

What Bupropion Neuraxpharm is and what it is used for
What you need to know before taking Bupropion Neuraxpharm
How to take Bupropion Neuraxpharm
Possible side effects
How to store Bupropion Neuraxpharm
Contents of the pack and other information

1. What Bupropion Neuraxpharm is and what it is used for

Bupropion Neuraxpharm is a prescription medicine used to treat depression. It acts on chemical substances in the brain called noradrenaline and dopamine.

2. Important information before taking Bupropion Neuraxpharm

When not to take Bupropion Neuraxpharm

if the patient is allergic to bupropion or any of the other ingredients of this medicine (listed in section 6),
if the patient is taking any other medicines containing bupropion,
if the patient suffers from epilepsy or has experienced seizures,
if the patient currently has or has previously had eating disorders (e.g. bulimia or anorexia nervosa),
if the patient has a brain tumour,
if the patient who abuses alcohol has recently stopped drinking alcohol or intends to do so,
if the patient has severe liver disease,
if the patient has recently stopped taking sedative medicines or intends to stop them during treatment with Bupropion Neuraxpharm,
if the patient is taking or has taken within the last two weeks antidepressant medicines called monoamine oxidase inhibitors (MAO inhibitors).

If any of the above situations apply to the patient, contact the doctor immediately
and do not take Bupropion Neuraxpharm.
Warnings and precautions
Before starting treatment with Bupropion Neuraxpharm, discuss this with your doctor or
pharmacist.
Children and adolescents
Bupropion Neuraxpharm is not recommended for use in children under 18 years of age.
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In children under 18 years of age being treated with antidepressant medicines, there is an increased risk of
suicidal thoughts and behaviours.
Adults
You should inform your doctor before starting treatment with Bupropion
Neuraxpharm:

if the patient regularly drinks large amounts of alcohol,
if the patient has diabetes and is using insulin or oral antidiabetic medicines,
if the patient has previously had a serious head injury or trauma,
if the patient has Brugada syndrome (a rare, genetically determined condition affecting heart rhythm) or if there is a family history of cardiac arrest or sudden death.

Bupropion Neuraxpharm may cause seizures in approximately 1 in 1000 patients.
The occurrence of this adverse effect is more likely in patients from the groups
mentioned above. If seizures occur during treatment, treatment with Bupropion Neuraxpharm must be discontinued.
Do not take any more of this medicine and contact your doctor immediately.

If the patient has bipolar disorder (extreme mood swings), because Bupropion Neuraxpharm may trigger an episode of this condition,
If the patient is taking other antidepressant medicines, because taking these medicines together with Bupropion Neuraxpharm may lead to serotonin syndrome, a potentially life-threatening condition (see “Bupropion Neuraxpharm and other medicines” in section 2),
If the patient has liver or kidney disease, because adverse effects may be more likely to occur.

If any of the above situations apply to the patient, contact the
treating doctor again before starting treatment with Bupropion Neuraxpharm. The doctor
may decide that treatment should be carried out under close supervision or recommend alternative treatment.
Suicidal thoughts and worsening of depressive symptoms
Patients with depression may sometimes experience thoughts of self-harm or suicide. These
behaviours may worsen when the patient first starts taking antidepressant
medicines, because it takes time before these medicines start to work, usually about two
weeks, but sometimes longer.
Such thoughts may occur more frequently:

if the patient previously had suicidal thoughts or thoughts of self-harm,
if the patient is a young adult. Clinical studies have shown an increased risk of suicidal behaviour in adults (under 25 years of age) with psychiatric disorders who were treated with antidepressant medicines. If thoughts of self-harm or suicide ever occur, contact the doctor immediately or go to hospital.

It may be helpful to inform a relative or friend that the patient has depression and
ask them to read this leaflet. The patient may ask them to inform him or her if they believe
the patient's depression is worsening or if changes in behaviour become concerning.
Bupropion Neuraxpharm and other medicines
If the patient is currently taking or has taken within the last fourteen days other medicines
called monoamine oxidase inhibitors (MAO inhibitors), contact the doctor without taking
Bupropion Neuraxpharm (see also: When not to take Bupropion Neuraxpharm, in section 2).
Tell your doctor or pharmacist about all medicines you are currently taking or
have recently taken, as well as any medicines you plan to take, including herbal remedies or
vitamins, even those purchased without a prescription. The doctor may adjust the dose of Bupropion
Neuraxpharm, recommend changing the dosing regimen, or discontinuation of other medicines.
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Some medicines must not be taken at the same time as Bupropion Neuraxpharm.
Some of these may increase the risk of seizures or convulsions. Other medicines
may increase the risk of other adverse effects. Examples of such medicines are listed below,
but this is not a complete list.
Seizures may occur more frequently than usual:

if the patient is taking other antidepressant medicines or medicines used to treat psychiatric disorders,
if the patient is taking theophylline, a medicine for asthma or lung diseases,
if the patient is taking tramadol, a strong painkiller,
if the patient has recently been taking or is currently taking sedative medicines or intends to stop taking them during treatment with Bupropion Neuraxpharm (see also When not to take Bupropion Neuraxpharm, in section 2),
if the patient is taking antimalarial medicines (such as mefloquine or chloroquine),
if the patient is taking stimulant medicines or other medicines that control body weight or appetite,
if the patient is taking steroids (orally or by injection),
if the patient is taking antibiotics called quinolones,
if the patient is taking certain types of antihistamines that may cause drowsiness,
if the patient is taking antidiabetic medicines.

If any of the above situations apply to the patient, contact the
treating doctor immediately before starting treatment with Bupropion Neuraxpharm. The doctor
will assess the risks and benefits of using Bupropion Neuraxpharm.
The likelihood of other adverse effects may increase:

if the patient is taking other antidepressant medicines (such as amitriptyline, fluoxetine, paroxetine, citalopram, escitalopram, venlafaxine, doxepin, desipramine or imipramine) or medicines for other psychiatric disorders (such as clozapine, risperidone, thioridazine or olanzapine). Bupropion Neuraxpharm may interact with some medicines used to treat depression and may cause changes in mental state (e.g. agitation, hallucinations, coma) and other adverse effects such as body temperature above 38°C, rapid heartbeat, unstable blood pressure, exaggerated reflexes, muscle rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea),
if the patient is taking medicines used to treat Parkinson's disease (levodopa, amantadine, orphenadrine),
if the patient is taking medicines that affect the metabolism of Bupropion Neuraxpharm (carbamazepine, phenytoin, valproic acid),
if the patient is taking certain medicines used to treat malignant tumours (such as cyclophosphamide, ifosfamide),
if the patient is taking ticlopidine or clopidogrel, mainly used to prevent stroke,
if the patient is taking β-adrenergic blocking agents (such as metoprolol),
if the patient is taking certain medicines for irregular heart rhythm (propafenone and flecainide),
if the patient is using nicotine patches as an aid to stop smoking.

If any of the above situations apply to the patient, contact the
treating doctor immediately before starting treatment with Bupropion Neuraxpharm.
Bupropion Neuraxpharm may be less effective:

If the patient is taking ritonavir or efavirenz, medicines used to treat HIV infection.

If this situation applies to the patient, inform the doctor. The doctor will
assess the effectiveness of Bupropion Neuraxpharm in the patient.
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It may be necessary to increase the dose or change the method of treating depression. Do not
increase the dose of Bupropion Neuraxpharm without the doctor's recommendation, as this may
increase the risk of adverse effects, including seizures.
Bupropion Neuraxpharm may reduce the effectiveness of certain medicines

If the patient is taking tamoxifen, used in the treatment of breast cancer. If this applies to the patient, inform the doctor. It may be necessary to change the method of treating depression.
If the patient is taking digoxin for heart problems. If this applies to the patient, inform the doctor. The doctor may consider adjusting the dose of digoxin.

Bupropion Neuraxpharm and alcohol
Alcohol may affect the action of Bupropion Neuraxpharm and taking them together may,
although rarely, cause nervousness or changes in mental state. Some patients become
more sensitive to alcohol while taking Bupropion Neuraxpharm. The doctor may
recommend abstaining from alcohol (beer, wine, spirits) or significantly reducing alcohol
consumption during treatment with Bupropion Neuraxpharm. If the patient currently drinks large amounts
of alcohol, do not stop drinking suddenly, as this may trigger a seizure.
Talk to the doctor about alcohol consumption before starting treatment with Bupropion
Neuraxpharm.
Effect on urine tests
Bupropion Neuraxpharm may affect laboratory test results for the presence of other
medicines. If the patient undergoes such a test, he or she should inform the doctor or
nurse that he or she is taking Bupropion Neuraxpharm.
Pregnancy and breastfeeding
Do not take Bupropion Neuraxpharm during pregnancy, if there is suspicion of
pregnancy or if pregnancy is planned, unless otherwise advised by the doctor. Before taking
any medicine during pregnancy, consult a doctor or pharmacist. Some, but not all,
studies suggest an increased risk of congenital malformations, particularly heart defects, in children whose
mothers used Bupropion Neuraxpharm. It is not known whether this was caused by the use of this medicine.
The ingredients of Bupropion Neuraxpharm may pass into breast milk. Before taking Bupropion
Neuraxpharm, consult a doctor or pharmacist.
Driving and operating machinery
If Bupropion Neuraxpharm causes dizziness or a feeling of emptiness in the head, do not
drive or operate machinery.

3. How to take Bupropion Neuraxpharm

This medicine should always be taken exactly as directed by the doctor or pharmacist. The treating physician will determine the dose individually for each patient. If in doubt, consult your doctor or pharmacist.

Improvement in the patient's condition may take some time. The full effect of the medicine may not become apparent until several weeks or months have passed. Even when the patient starts to feel better, the treating physician may recommend continuing treatment with Bupropion Neuraxpharm to prevent recurrence of depression.

What dose should be taken?
Bupropion Neuraxpharm is available in a 300 mg strength. For a 150 mg dose, another suitable product available on the market should be used.

The usual recommended dose for adults is one 150 mg tablet once daily.

The treating physician may recommend increasing the dose to 300 mg once daily if there is no improvement after several weeks of treatment.

Bupropion Neuraxpharm should be taken in the morning. Do not take Bupropion Neuraxpharm more frequently than once daily.

The tablet has a special coating that slowly releases the medicine into the gastrointestinal tract. The patient may notice something in the stool that looks like a whole tablet. This is the empty tablet shell, which has been eliminated from the body.

Bupropion Neuraxpharm tablets must be swallowed whole. Do not chew, crush, or divide the tablets – doing so may lead to overdose due to rapid release of the medicine into the body. This may increase the risk of adverse effects, including seizures.

For some patients, a dose of 150 mg once daily may be sufficient throughout treatment. The treating physician may recommend this dose if the patient has liver or kidney disease.

How long to continue treatment?
Only the doctor together with the patient can decide how long treatment with Bupropion Neuraxpharm should continue. It may take weeks or months before any improvement is observed. The patient should regularly discuss depressive symptoms with the treating physician to determine the appropriate duration of treatment. Even if the patient feels better, the treating physician may recommend continuing Bupropion Neuraxpharm to prevent recurrence of depression.

Taking more Bupropion Neuraxpharm than recommended
Taking too many tablets may cause seizures or a seizure attack. Do not delay. Seek immediate medical attention from a doctor or the nearest hospital emergency department.

If a dose of Bupropion Neuraxpharm is missed
If a dose is missed, wait and take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Bupropion Neuraxpharm
Do not stop taking Bupropion Neuraxpharm or reduce the dose without first consulting the treating physician.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
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4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Serious adverse reactions
Seizures or convulsions
Seizures (convulsions or fits) may occur in approximately 1 in 1,000 patients taking Bupropion Neuraxpharm.
The likelihood is higher in patients taking higher than recommended doses, taking certain other medicines,
or who are in a group at increased risk of seizures. If in doubt, consult your doctor.
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If a seizure occurs, contact your doctor immediately. Do not take any more of the medicine.
Allergic reactions
Some patients may experience allergic reactions to Bupropion Neuraxpharm. These may include:

skin redness or rash (such as erythema multiforme), blisters or itchy lumps (urticaria) on the skin; some rashes may require hospitalization, especially if mouth pain or eye pain also occur,
unusual wheezing or difficulty breathing,
swelling of the eyelids, lips or tongue,
muscle or joint pain,
collapse or brief loss of consciousness.

If any symptoms of an allergic reaction occur, contact your doctor immediately. Do not take any more of the medicine.
Allergic reactions may be prolonged. If your doctor has prescribed medication to relieve allergic symptoms, complete the full course of treatment.
Drug-induced lupus erythematosus or worsening of lupus symptoms
Frequency unknown – frequency cannot be estimated from the available data from patients taking Bupropion Neuraxpharm.
Lupus is an autoimmune disorder affecting the skin and other organs. If lupus flares, skin rash, or skin changes (especially on areas of skin exposed to sunlight) occur during treatment with Bupropion Neuraxpharm, contact your doctor immediately, as discontinuation of treatment may be necessary.
Acute generalized exanthematous pustulosis (AGEP)
Frequency unknown – frequency cannot be estimated from the available data from patients taking Bupropion Neuraxpharm.
AGEP symptoms include a rash with pustules (pus-filled blisters).
If you develop a rash with pustules filled with pus, contact your doctor immediately, as discontinuation of treatment may be necessary.
Other adverse reactions
Very common adverse reactions: may affect more than 1 in 10 patients.

difficulty sleeping; ensure that Bupropion Neuraxpharm is taken in the morning,
headache,
dry mouth,
nausea, vomiting.

Common adverse reactions: may affect up to 1 in 10 patients.

fever, dizziness, itching, sweating, skin rash (sometimes due to allergic reaction),
chills, tremors, weakness, fatigue, chest pain,
feelings of anxiety or agitation,
abdominal pain or other gastrointestinal complaints (constipation), altered taste sensation, loss of appetite (anorexia),
increased blood pressure (sometimes marked), facial flushing,
ringing in the ears, visual disturbances.

Uncommon adverse reactions: may affect up to 1 in 100 patients.

feeling of depression (see also section 2: Warnings and precautions, Suicidal thoughts and worsening of depressive symptoms),
feeling of disorientation,
difficulty concentrating, Page 6 of 9
increased heart rate,
weight loss.

Rare adverse reactions: may affect up to 1 in 1,000 patients.

seizures.

Very rare adverse reactions: may affect up to 1 in 10,000 patients.

palpitations, fainting,
muscle twitching, muscle stiffness, uncontrolled movements, problems with walking or coordination,
restlessness, irritability, hostility, aggression, strange dreams, tingling or numbness, memory loss,
yellowing of the skin or whites of the eyes ( jaundice ), which may be due to increased liver enzyme activity, hepatitis,
severe allergic reactions; rash accompanied by muscle and joint pain,
changes in blood sugar levels,
urinating more or less frequently than usual,
urinary incontinence (involuntary urination, uncontrolled leakage of urine),
severe skin reactions, which may involve the mouth and other parts of the body and may be life-threatening,
worsening of psoriasis (red, scaly patches on the skin),
feelings of unreality or detachment ( depersonalization ), seeing or hearing things that are not there ( hallucinations ), experiencing or believing in unreal things ( delusions ), excessive suspiciousness ( paranoia ).

Frequency unknown:
Other adverse reactions have occurred in an unknown, although small, number of patients:

thoughts of self-harm or suicide during treatment with Bupropion Neuraxpharm or shortly after stopping it (see section 2 "Important information before taking Bupropion Neuraxpharm"). If you have such thoughts, contact your doctor or go to hospital immediately,
loss of contact with reality and impaired thinking or judgment ( psychosis ); other symptoms may include hallucinations and (or) delusions,
stuttering,
reduced number of red blood cells (anaemia), reduced number of white blood cells (leukopenia), and reduced number of platelets (thrombocytopenia),
low sodium levels in the blood (hyponatremia),
changes in mental state (e.g. agitation, hallucinations, coma), and other symptoms such as body temperature above 38°C, rapid heartbeat, unstable blood pressure, increased reflexes, muscle rigidity, lack of coordination and (or) gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) when Paritdam is taken together with medicines used to treat depression (such as paroxetine, citalopram, escitalopram, fluoxetine and venlafaxine).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store Bupropion Neuraxpharm

Keep this medicine out of sight and reach of children.
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Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Bupropion Neuraxpharm contains
The active substance is bupropion hydrochloride. Each tablet contains 300 mg of bupropion hydrochloride (equivalent to 260.40 mg of bupropion).
The other ingredients are:
Tablet core: povidone K 90, L-cysteine hydrochloride monohydrate, colloidal anhydrous silica, glycerol dibehenate, magnesium stearate.
Coating: ethylcellulose, povidone K 90, polyethylene glycol 1500, methacrylic acid-ethyl acrylate copolymer (1:1), 30% dispersion containing sodium lauryl sulfate and polysorbate 80, hydrated colloidal silica, triethyl citrate.
Printing ink: shellac, black iron oxide (E 172), and propylene glycol.

What Bupropion Neuraxpharm looks like and contents of the pack
Bupropion Neuraxpharm 300 mg prolonged-release tablets are cream-white to light yellow, round tablets, printed in black with "GS2" on one side and the other side smooth. The diameter of the tablet is approximately 9.3 mm.
Blister pack: OPA/Al/PVC-Al blisters containing 30 or 90 tablets, in a cardboard box.
For more detailed information, please contact the Marketing Authorisation Holder or Parallel Importer.

Marketing Authorisation Holder in the Czech Republic, country of export:
Neuraxpharm Bohemia s.r.o., náměstí Republiky 1078/1, 110 00 Prague 1 – Nové Město, Czech Republic

Manufacturer:
neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert Str. 23, 40764 Langenfeld, Germany
Laboratorios Lesvi, S.L., Avda. de Barcelona 69, Sant Joan Despí, 08970 Barcelona, Spain

Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Marketing Authorisation Number in the Czech Republic, country of export: 30/274/20-C
Parallel Import Licence Number: 138/23

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria Bupropion neuraxpharm 300 mg Tabletten mit veränderter Wirkstofffreisetzung
Czech Republic Bupropion Neuraxpharm
Netherlands Bupropion HCl Neuraxpharm 300 mg tabletten met gereguleerde afgifte
Germany Bupropion-neuraxpharm 300 mg Tabletten mit veränderter Wirkstofffreisetzung
Poland Bupropion Neuraxpharm
Slovakia Bupropion 300 mg Tablety s riadeným uvoľňovaním

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